Table 3.

Adverse Events and Serious Adverse Events

	CYC		MMF
	No. of AEs	No. of patients	No. of AEs	No. of patients
Adverse event (AE)*
Leukopenia†	51	30	5	4
Neutropenia	7	5	3	3
Anemia	26	13	18	8
Thrombocytopenia	7	4	0	0
Hematuria	2	2	3	3
Pneumonia	4	4	6	5
Serious adverse event (SAE)
Number of patients with SAEs	22		27
Total number of SAEs	36		42
Related to treatment‡	8		3
Related to underlying disease‡	16		16
Due to other causes‡,§	11		22
Death	11		5

^*pre-defined by protocol as likely to be related to study drug and to warrant protocol-defined management (except for pneumonia): anemia = Hgb <10 gm/dl or <9 for those with Hgb <11 at enrollment; leukopenia = WBC <2500; neutropenia = neutrophils <1000; thrombocytopenia = platelets <100,000; hematuria = >25 red blood cells (or 10–15 red blood cells on more than one urinalysis) in absence of urinary tract infection or menses

^†p<0.05; Fisher’s exact test comparing the number of patients experiencing AE between the two groups

^‡according to consensus classification by Morbidity and Mortality Committee

^§Other causes included cancer (n=3); renal/bladder (n=2); syncope/seizures (n=3); hematologic (including anemia and blood clot; n=3); GI (dysphagia/vomiting, gastroenteritis, bile duct obstruction, SSc bowel disorder; n=7); musculoskeletal (n=7); respiratory infection (n=9); cardiac (including heart failure, palpitation, arrhythmias,, chest pain, pericarditis, ischemic heart disease; n=20); miscellaneous (including weight loss, sulfa allergy and elective surgery; n=6)